← Trials/Trial dossier/NCT05924425

DARIDOR-ALZ

RecruitingPhase 4

Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease

Lead sponsor

University Hospital, Montpellier

Asset

Daridorexant

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•Alzheimer's disease•MMSE 12-26

Primary endpoint

•Total Sleep Time (TST)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05924425

Org study IDRECHMPL22_0529

Timeline

Milestones

Study first posted2023-06-29actual

Study start2024-03-13actual

Last update posted2026-06-25actual

Primary completion2027-05-13estimated

Study completion2028-03-13estimated

Assets

Drug assets

Daridorexant

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age60 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

•Age [60-85] years old

•Outpatients

•Pre-screening:

-Complaints of dissatisfaction with sleep quantity or quality, despite adequate opportunity for sleep, at least 3 nights per week and for at least 3 months, and

-Total sleep time causes clinically significant distress or impairment in daytime functioning, and

-Total sleep time estimated by interview was below 6 hours, on at least 3 nights per week and for at least 1 month before screening

•Baseline PSG (at randomization) assessed TST < 6 hours and WASO > 1 hour

•Diagnosis of MCI and AD patients at an early stage according to the NIA diagnosis criteria (core clinical criteria for MCI, positive CSF Aβ42 and/or positive plasma biomarker, and neuronal injury (hippocampal and/or temporal atrophy by MRI))

•MMSE from 12 to 26

•Clinical Dementia Rating CDR from 0.5 to 2

•Use of CNS-active medications is permitted provided the dose has been stable for at least 3 months, including: anticholinesterase drugs (rivastigmine, donepezil, galantamine) or memantine, antidepressants SSRI (e.g. fluoxetine, sertraline, paroxetine…), SNRI (e.g. venlafaxine, duloxetine), neuroleptics (e.g. clozapine, olanzapine, aripiprazole...) or drug for pain level 2 (codeine, tramadol).

•For a male subject who is not sterilized and is sexually active with a female partner of childbearing potential, no contraceptive methods are needed

Non inclusion criteria :

•Patients significantly dependent on caregivers

•Institutionalized patients

•Analphabetism or subjects unable to read or/and write

•Patients unable to perform the neuropsychological tests

•Patients unable to complete the study instruments (sleep diary)

•Planned longer stay outside the region that prevents compliance with the visit schedule

•Patients who cannot be followed up for at least 2 months

•History of narcolepsy and/or cataplexy

•History of drug or alcohol abuse or addiction

•History of diagnosed and characterized psychiatric disorders (DSM-5), cured or stabilized (with or without the same treatment for at least 3 months) and excluding any current characterized psychiatric disorder (DSM-5), the diagnosis of which is established by a psychiatrist trained in geriatric psychiatry

•Moderate and severe liver failure

•PSG baseline evidence of significant/severe sleep-related breathing disorder (defined as >30 apnea/hypopnea episodes per hour)

•Treatments interfering with sleep-wake patterns

•Use of hypnotics (benzodiazepines, zolpidem, zopiclone) or drug for pain level 3 (morphine and derivatives)

•Hypersensitivity to the active substance or to any of the excipients listed in the Summary of Product Characteristics (SmPC)

•Forbidden and restricted concomitant medications:

-Concomitant CNS-depressant medicinal products

-CYP3A4 inhibitors

-CYP3A4 inducers

•Participation in another clinical trial or administration of an investigational product

•Protected population according to articles of the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship/curatorship).

•Subjects not covered by public health insurance

•Failure to obtain written informed consent after a reflection period

Endpoints (43)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Other (unclassified)

Amyloid biomarkers

Global cognition

Other clinical outcomes

Fluid / digital biomarkers

Safety / tolerability / PK

Global cognition

3 endpoints

Secondary/protocol endpoint

Change in cognition

Time frame:from baseline to the end of each period A/B (Month1/Month2)

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change in cognition

Time frame:from baseline to Month 6

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change in cognition

Time frame:from baseline to Month 12

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Behavior / neuropsychiatric

26 endpoints

Primary/protocol endpoint

Change in Total Sleep Time (TST).

Time frame:from baseline to the end of each period A/B (Month1/Month2)

change from baseline, improvement

Secondary/protocol endpoint

Change in the wake time after sleep onset (WASO)

Time frame:from baseline to the end of each period A/B (Month1/Month2)

change from baseline, improvement

Secondary/protocol endpoint

Change in Latency to Persistent Sleep (LPS)

Time frame:from baseline to the end of each period A/B (Month1/Month2)

change from baseline, improvement

Secondary/protocol endpoint

Measure of sleep time at stage 1-2 during polysomnography

Time frame:from baseline to the end of each period A/B (Month1/Month2)

categorical status, descriptive

Secondary/protocol endpoint

Measure of sleep time at stage 3 during polysomnography

Time frame:from baseline to the end of each period A/B (Month1/Month2)

categorical status, descriptive

Secondary/protocol endpoint

Changes in sleep and wake duration

Time frame:from baseline to the end of each period A/B (Month1/Month2)

ratio, descriptive

Secondary/protocol endpoint

Changes in sleep and wake duration

Time frame:from baseline to Month 6

ratio, descriptive

Secondary/protocol endpoint

Changes in sleep and wake duration

Time frame:from baseline to Month 12

ratio, descriptive

Secondary/protocol endpoint

Variations in the results of self-reported questionnaires administered to patients - Epworth Sleepiness Scale (ESS)

Time frame:from baseline to the end of each period A/B (Month1/Month2)

descriptive

Secondary/protocol endpoint

Variations in the results of self-reported questionnaires administered to patients - ESS

Time frame:from baseline to Month 6

descriptive

Secondary/protocol endpoint

Variations in the results of self-reported questionnaires administered to patients - Epworth Sleepiness Scale (ESS)

Time frame:from baseline to Month 12

descriptive

Secondary/protocol endpoint

Variations in the results of self-reported questionnaires administered to patients - Insomnia Daytime Symptoms and Impacts (IDSIQ)

Time frame:from baseline to the end of each period A/B (Month1/Month2)

change from baseline, improvement

Secondary/protocol endpoint

Variations in the results of self-reported questionnaires administered to patients - Insomnia Daytime Symptoms and Impacts (IDSIQ)

Time frame:from baseline to Month 6

change from baseline, improvement

Secondary/protocol endpoint

Variations in the results of self-reported questionnaires administered to patients - Insomnia Daytime Symptoms and Impacts (IDSIQ)

Time frame:from baseline to Month 12

change from baseline, improvement

Secondary/protocol endpoint

Variations in the results of self-reported questionnaires administered to patients - Sleep Diaries

Time frame:from baseline to the end of each period A/B (Month1/Month2)

descriptive

Secondary/protocol endpoint

Variations in the results of self-reported questionnaires administered to patients - Sleep Diaries

Time frame:from baseline to Month 6

descriptive

Secondary/protocol endpoint

Variations in the results of self-reported questionnaires administered to patients - Sleep Diaries

Time frame:from baseline to Month 12

descriptive

Secondary/protocol endpoint

Variations in the results of health assessment questionnaires administered to patients - Neuropsychiatric Inventory (NPI)

Time frame:from baseline to the end of each period A/B (Month1/Month2)

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/protocol endpoint

Variations in the results of health assessment questionnaires administered to patients - Neuropsychiatric Inventory (NPI)

Time frame:from baseline to Month 6

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/protocol endpoint

Variations in the results of health assessment questionnaires administered to patients - Neuropsychiatric Inventory (NPI)

Time frame:from baseline to Month 12

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/protocol endpoint

Variations in the results of health assessment questionnaires administered to patients - Beck Depression Inventory (BDI)

Time frame:from baseline to the end of each period A/B (Month1/Month2)

descriptive

Secondary/protocol endpoint

Variations in the results of health assessment questionnaires administered to patients - Beck Depression Inventory (BDI)

Time frame:from baseline to Month 6

descriptive

Secondary/protocol endpoint

Variations in the results of health assessment questionnaires administered to patients - Beck Depression Inventory (BDI)

Time frame:from baseline to Month 12

descriptive

Secondary/protocol endpoint

Variations in the results of health assessment questionnaires administered to patients - EuroQoL-5D (EQ5D)

Time frame:from baseline to the end of each period A/B (Month1/Month2)

descriptive

Secondary/protocol endpoint

Variations in the results of health assessment questionnaires administered to patients - EuroQoL-5D (EQ5D)

Time frame:from baseline to Month 6

descriptive

Secondary/protocol endpoint

Variations in the results of health assessment questionnaires administered to patients - EuroQoL-5D (EQ5D)

Time frame:from baseline to Month 12

descriptive

Amyloid biomarkers

4 endpoints

Secondary/protocol endpoint

Change in blood AD biomarkers and proinflammatory cytokines levels

Time frame:from baseline to the end of each period A/B (Month1/Month2)

Neurofilament light (NfL)

change from baseline, improvement

Secondary/protocol endpoint

Change in blood AD biomarkers and proinflammatory cytokines levels

Time frame:from baseline to Month 6

Neurofilament light (NfL)

change from baseline, improvement

Secondary/protocol endpoint

Change in blood AD biomarkers and proinflammatory cytokines levels

Time frame:from baseline to Month 12

Neurofilament light (NfL)

change from baseline, improvement

Secondary/protocol endpoint

Concentration of CSF AD biomarkers and proinflammatory cytokines

Time frame:baseline

Neurofilament light (NfL)

concentration, descriptive

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

Concentration of CSF orexinA/hypocretin

Time frame:baseline

concentration, descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Percentage of Serious Adverse Events Occurring

Time frame:between baseline and 12 months

threshold achievement, event

Other clinical outcomes

3 endpoints

Secondary/protocol endpoint

Change in blood pressure

Time frame:from baseline to the end of each period A/B (Month1/Month2)

change from baseline, improvement

Secondary/protocol endpoint

Change in blood pressure

Time frame:from baseline to Month 6

change from baseline, improvement

Secondary/protocol endpoint

Change in blood pressure

Time frame:from baseline to Month 12

change from baseline, improvement

Other (unclassified)

5 endpoints

Secondary/protocol endpoint/low confidence

Measure of number of wake bouts on the whole night

Time frame:from baseline to the end of each period A/B (Month1/Month2)

event count, event

Secondary/protocol endpoint/low confidence

Measure of number of wake bouts per quarter of the night

Time frame:from baseline to the end of each period A/B (Month1/Month2)

event count, event

Secondary/protocol endpoint/low confidence

Variations in the results of self-reported questionnaires administered to patients - Insomnia Severity Index (ISI)

Time frame:from baseline to the end of each period A/B (Month1/Month2)

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Variations in the results of self-reported questionnaires administered to patients - Insomnia Severity Index (ISI)

Time frame:from baseline to Month 6

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Variations in the results of self-reported questionnaires administered to patients - Insomnia Severity Index (ISI)

Time frame:from baseline to Month 12

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.